K901038 is an FDA 510(k) clearance for the SPS 550-IPS (INTEGRATED PATIENT STATION). This device is classified as a System, Dialysate Delivery, Single Pass (Class II - Special Controls, product code FIL).
Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on April 19, 1990, 44 days after receiving the submission on March 6, 1990.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K901038 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 1990 |
| Decision Date | April 19, 1990 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FIL — System, Dialysate Delivery, Single Pass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |